A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

NCT00002246 | Completed Phase 3

• 2 other identifiers: 244EAI455-064
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 5

Brief Summary

The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal cord) in HIV-positive patients.

Conditions

AIDS Dementia Complex; HIV Infections

Keywords

AIDS Dementia Complex; Zidovudine; Stavudine; Reverse Transcriptase Inhibitors

Interventions

Stavudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• You may be eligible for this study if you:
• Are HIV-positive.
• Are at least 13 years old (need consent if under 18).
• Have AIDS Dementia Complex.
• Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study entry.
• Agree to use effective methods of birth control during the study.
• Are available for at least 16 weeks of study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have ever taken d4T.
• Have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study.
• Are pregnant or breast-feeding.
• Abuse alcohol or drugs.
• Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires treatment at the time of study enrollment.
• Have received certain medications.
• Cannot take medications by mouth.
• Have severe diarrhea for at least 7 days in a row within 30 days prior to study entry.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

HIV Neurobehavioral Research Ctr

San Diego, California, 92103, United States

Location

AIDS ReSEARCH Alliance

West Hollywood, California, 90069, United States

Location

Mount Sinai Hosp

New York, New York, 100296574, United States

Location

National Centre in HIV Epidemiology and Clinical Research

Sydney, Australia

Location

Charing Cross and Westminster Med School

London Southwest 10, United Kingdom

Location

MeSH Terms

Conditions

AIDS Dementia Complex; HIV Infections

Interventions

Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• B Brew

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: October 1, 1997
• Primary Completion: March 1, 1999
• Study Completion: March 1, 1999
• Last Updated: May 4, 2011

Record last verified: 2011-04

Locations

GB (1); AU (1); US (3)